Adaptive system for blood fluid removal

ABSTRACT

Methods for monitoring patient parameters and blood fluid removal system parameters include identifying those system parameters that result in improved patient parameters or in worsened patient parameters. By comparing the patient&#39;s past responses to system parameters or changes in system parameters, a blood fluid removal system may be able to avoid future use of parameters that may harm the patient and may be able to learn which parameters are likely to be most effective in treating the patient in a blood fluid removal session.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/693,535 filed Sep. 1, 2017, which is a continuation of U.S. patentapplication Ser. No. 13/424,533 filed Mar. 20, 2012, now U.S. Pat. No.9,750,862, which claims benefit of and priority to U.S. ProvisionalApplication No. 61/480,528 filed Apr. 29, 2011, which claims benefit ofand priority to U.S. Provisional Application No. 61/480,530 filed Apr.29, 2011, which claims benefit of and priority to U.S. ProvisionalApplication No. 61/480,532 filed Apr. 29, 2011, which claims benefit ofand priority to U.S. Provisional Application No. 61/480,544 filed Apr.29, 2011, which claims benefit of and priority to U.S. ProvisionalApplication No. 61/480,539 filed Apr. 29, 2011, which claims benefit ofand priority to U.S. Provisional Application No. 61/480,541 filed Apr.29, 2011, which claims benefit of and priority to U.S. ProvisionalApplication No. 61/480,535 filed Apr. 29, 2011, and the disclosures ofeach of the above-identified applications are hereby incorporated byreference in their entirety.

FIELD

The present disclosure relates generally to devices, systems and methodsfor monitoring patient and system parameters of blood fluid removalsessions.

BACKGROUND

Patients who undergo hemodialysis or other procedures that remove fluidfrom blood often die of cardiac complications. Many factors maycontribute to such death, including stress placed on the heart due tothe increased blood fluid volume in these patients. Increased fluidconcentrations and inability to appropriately remove waste products fromthe blood can also contribute to electrolyte and pH imbalance that canaffect cardiac contractility and efficiency. Further, rapid changes influid volume or pH or electrolyte concentration of the blood duringhemodialysis or other fluid removal processes may place additionalstress on the heart and may contribute to the high rate of morbidity forpatients who undergo blood fluid removal procedures.

When a patient reaches a point where routine blood fluid removalprocedures are prescribed, the patient undergoes periodic examinationsthat allow a healthcare provider to set various parameters of the bloodfluid removal procedures, such as the profile of fluid removal, thecomposition of dialysate or replacement fluid employed, and the like.These examinations typically occur once a month in accordance withcurrent standards of care.

While such monthly examinations somewhat provide for blood fluid removalsessions tailored according to the patient's needs, it may be desirableto provide a more systematic evaluation of the patient and the bloodfluid removal session parameters to achieve a more patient-specifictherapy.

SUMMARY

This disclosure, among other things, describes devices, systems andmethods for monitoring patient parameters and blood fluid removal systemparameters and identifying those system parameters that result inimproved (more effective) patient parameters or in worsened (lesseffective) patent parameters. By comparing the patient's past responsesto system parameters or changes in system parameters, a blood fluidremoval system may be able to avoid future use of parameters that mayharm the patient and may be able to learn which parameters are likely tobe most effective in treating the patient in a blood fluid removalsession.

In various embodiments described herein, a method includes (i)initiating a blood fluid removal session with initial system parameters;(ii) acquiring a first set of data regarding one or more patientphysiological parameters; (iii) storing the first data set in a “best”or “most effective to date” data set memory; (iv) associating theinitial system parameters in an increased effectiveness lookup tablewith the first data set; (v) adjusting at least one parameter of theblood fluid removal session to arrive at adjusted system parameters;(vi) acquiring a second set of data regarding the one or more patientphysiological parameters after the at least one parameter of the bloodfluid removal session has been adjusted; and (vii) if at least one valueof the second data set is closer to the target value than acorresponding value of at least one value of the first data set:replacing the first data set in the most effective to date data setmemory with the second data set; storing in the increased effectivenesslookup table data regarding the second data set; and associating dataregarding the adjusted system parameters with the second data set.

In embodiments, a method carried out by a blood fluid removal systemincludes (i) acquiring data regarding one or more of one or more patientphysiological parameters and time since last blood fluid removalsession; (ii) acquiring data regarding one or more target outcomes of ablood fluid removal session; (iii) determining whether at least one ofthe one or more target outcomes is within a predetermined range of a atleast one corresponding prior target outcome stored in a lookup table,wherein the lookup table comprises data regarding system parameters usedin one or more prior blood fluid removal sessions of the patient; (iv)determining whether the at least one target outcome was achieved withthe system parameters used in the prior blood fluid removal session; (v)if the at least one target outcome is determined to have been achieved,determining whether at least one of the patient parameters or time sincelast blood fluid removal session is within a predetermined range of atleast one corresponding parameter stored in the lookup table; and (vi)initiating a blood fluid removal session employing the system parametersused for the prior blood fluid removal session if the at least onepatient parameter or time since last blood fluid removal session isdetermined to be within a predetermined range.

In embodiments, a method carried out by a blood fluid removal systemincludes (i) collecting first data regarding a patient, the dataincluding one or more of a physiological parameter and time since lastblood fluid removal session; (ii) collecting second data regardingsystem parameters employed in blood fluid removal sessions of thepatient; (iii) determining, based on the first and second collecteddata, whether at least one physiological parameter of the patientimproved as a result of the system parameters employed; (iv) determiningwhether a value of current patient data is within a predetermined rangeof a corresponding value of first collected data; and (v) employing thesystem parameters that resulted in improvement, if such parameters aredetermined to exist and if the current patient data is determined to bewithin the predetermined range.

Blood fluid removal systems configured to carry out the methodsdescribed herein are also presented, as are computer readable mediumthat, when executed, cause a blood fluid removal system to carry out themethods described herein.

One or more embodiments of the systems, devices and methods describedherein may provide one or more advantages over prior systems, devicesand methods for blood fluid removal in patients. Such advantages will beapparent to those skilled in the art upon reading the following detaileddescription.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated into and form a partof the specification, illustrate several embodiments of the presentdisclosure and, together with the description, serve to explain theprinciples of the disclosure. The drawings are only for the purpose ofillustrating embodiments of the disclosure and are not to be construedas limiting the disclosure.

FIGS. 1-7 are flow diagrams illustrating methods in accordance withvarious embodiments described herein.

FIG. 8 is a schematic graphical representation of monitored data (notactual data) shown for purposes of illustration.

FIG. 9 is a flow diagram illustrating an embodiment of a methoddescribed herein.

FIGS. 10-12 are schematic block diagrams showing interaction of bloodfluid removal devices with a patient showing flow of blood (dashedarrows) and fluid (solid arrows), which blood fluid removal devices maybe used in various embodiments described herein.

FIG. 13 is a schematic block diagram showing flow paths and some controlmechanisms for controlling flow of concentrate into fluid for use in ablood fluid removal process.

FIGS. 14-15 are schematic block diagrams of some components of bloodfluid removal devices that are configured to various system parameters.

The schematic drawings presented herein are not necessarily to scale.Like numbers used in the figures refer to like components, steps and thelike. However, it will be understood that the use of a number to referto a component in a given figure is not intended to limit the componentin another figure labeled with the same number. In addition, the use ofdifferent numbers to refer to components is not intended to indicatethat the different numbered components cannot be the same or similar.

DETAILED DESCRIPTION

In the following detailed description, reference is made to theaccompanying drawings that form a part hereof, and in which are shown byway of illustration several embodiments of devices, systems and methods.It is to be understood that other embodiments are contemplated and maybe made without departing from the scope or spirit of the presentdisclosure. The following detailed description, therefore, is not to betaken in a limiting sense.

All scientific and technical terms used herein have meanings commonlyused in the art unless otherwise specified. The definitions providedherein are to facilitate understanding of certain terms used frequentlyherein and are not meant to limit the scope of the present disclosure.

As used in this specification and the appended claims, the singularforms “a”, “an”, and “the” encompass embodiments having pluralreferents, unless the content clearly dictates otherwise.

As used in this specification and the appended claims, the term “or” isgenerally employed in its sense including “and/or” unless the contentclearly dictates otherwise.

As used herein, “have”, “having”, “include”, “including”, “comprise”,“comprising” or the like are used in their open ended sense, andgenerally mean “including, but not limited to.”

As used herein, a “patient for which a blood fluid removal session isindicated” is a patient that has undergone, is undergoing, or is likelyto undergo at least one blood fluid removal session. In general, suchpatients are fluid overloaded patients, such as patients suffering fromheart failure, chronic kidney disease, or acute kidney failure. Oftensuch patients are stage 3 to stage 5 chronic kidney disease patients,are unresponsive or under-responsive to diuretics, or the like.

As used herein, a “blood fluid removal process,” or the like, refers toa process from which fluid is removed from blood of a patient and theblood is returned to the patient. In most cases, the blood is alsocleaned; i.e., waste products are removed from the blood and cleanedblood is returned to the patient. Examples of blood fluid removalprocesses include ultrafiltration, hemofiltration, hemodialysis,hemodiafiltration, peritoneal dialysis and the like. Any patient forwhich blood fluid removal is indicated may benefit from the devices,systems and methods described herein.

As used herein, “effective” or the like, as it relates to patientparameters, refers to the how close one or more patient parameters areto one or more target for the one or more parameters. Thus, a “mosteffective” patient parameter to date is a patient parameter at a giventime that is closer to the target than the same parameter measured atany previous time. A “more effective” patient parameter is a parametermeasured at a given time that is closer to the target than the sameparameter measured at another time. A “least effective” patientparameter to date is a patient parameter at a given time that is fartherfrom the target than the same parameter measured at any previous time. A“less effective” patient parameter is a parameter measured or observedat a given time that is farther from the target than the same parametermeasured at another time.

This disclosure, among other things, describes devices, systems andmethods for monitoring patient physiological parameters and blood fluidremoval system parameters and identifying those system parameters thatresult in improved or more effective physiological parameters or inworsened physiological parameters. By comparing the patient's pastresponses to system parameters or changes in system parameters, a bloodfluid removal system may be able to avoid future use of parameters thatmay harm the patient and may be able to learn which parameters arelikely to be most effective in treating the patient in a blood fluidremoval session.

Referring to FIG. 1, a high level schematic overview of embodiments ofthe present disclosure is shown. As shown in FIG. 1, a learningalgorithm 520 is employed to determine what system parameters work wellto produce desired patient physiological results based on input. Anysuitable input variable 500 may be considered by the algorithm 520 inthe learning process. For example, variables such as how long it hasbeen since the patient's last blood removal session may be input. Suchinput could be important as patients undergoing, for example,hemodialysis on a Monday, Wednesday, Friday schedule are most likely tosuffer an adverse cardiac event just prior to, during or after theMonday blood fluid removal session. Accordingly, the algorithm 520 mayconsider whether a different set of system parameters should be employedwhen the patient has not undergone a session in 72 hours relative towhen the patient has not undergone a session in 48 hours. Inputvariables 500 may also include whether the patient has limited time toundergo a blood fluid removal session. The algorithm 520 can determinewhether a faster fluid removal rate should be used or whether a partialsession at a reduced fluid removal rate would likely be most effectivebased on the patient's history of response to fast fluid removal rates.Alternatively, the patient may have additional time to undergo a bloodfluid removal session, and the algorithm 520 can take such input 500into account to determine whether there may be an advantage to slowerfluid removal rates or slower adjustment of a concentration of anelectrolyte based on the patient's history. Of course, it will beunderstood that any other suitable input variables 500 may be enteredregarding target outcomes (e.g., quick session, long session, etc.),patient history (e.g., time since last session), or the like. Inembodiments, input that takes into account future patient behavior orneeds may be entered into the system. For example, if a patient knowsthat they will miss a session or the time until their next session willbe delayed from normal, time until next session may be entered, whichmay affect the system parameters (e.g., may remove additional fluid,etc.). By way of another example, if the patient knows that they willeat or drink an amount more than optimal before the session, expectedconsumption levels may be input in the system.

As shown in FIG. 1, the algorithm 520, based on input variables 500, andpatient physiological variables 510 may determine appropriate systemvariables 530 to employ based on the patient's history with blood fluidsessions under the algorithm. During a blood fluid session, systemvariables 530 may be changed and the patient physiological response maybe monitored in response to the changed system variables. If one or moreof the patient's physiological variables 510 improve or become “moreeffective”, the algorithm 530 can associate the changed system variables530 with the increased effectiveness patient outcome so that the changedsystem variables 530 may be used later in the session or in a futuresession when the patient has a similar set of physiological variables510. If one or more of the patient's physiological variables 510 becomeless effective, the algorithm 530 can associate the changed systemvariables 530 with a less effective patient outcome so that the changedsystem variables 530 may be avoided later in the session or in a futuresession when the patient has a similar set of physiological variables510.

In embodiments, the physiological variables 510 are monitored by sensorsthat feed data regarding the variables directly into the algorithm 520or electronics running the algorithm. The sensors may monitor fluidvolume in the patient's blood; fluid volume in the patient's tissue;concentrations of electrolytes in the patient's blood; pH of thepatient's blood; one or more cardiovascular parameter of the patient,such as blood pressure, heart rhythm, heart rate; or combinations orindicators thereof. The sensors may monitor the patient physiologicalparameters before, during or after a blood fluid removal session.

Any suitable sensor may be employed. Examples of sensors and systemsthat may be employed with regard to blood fluid volumes and tissue fluidvolumes are discussed in U.S. Provisional Patent Application No.61/480,528, filed on Apr. 29, 2011, entitled FLUID VOLUME MONITORING FORPATIENTS WITH RENAL DISEASE and having attorney docket no. P0041416.00;and U.S. Provisional Patent Application No. 61/480,530, filed on Apr.29, 2011, entitled MONITORING FLUID VOLUME FOR PATIENTS WITH RENALDISEASE, and having attorney docket no. P0041417.00, which applicationsare hereby incorporated herein by reference in their respectiveentireties to the extent that they do not conflict with the presentdisclosure. Sensors for monitoring tissue fluid volume, blood fluidvolume, fluid flow or volume diverted from blood and the like typicallymonitor fluid indirectly, and directly monitor an indicator of fluidvolume, flow or the like. For example, a sensor may indirectly monitorhematocrit (the portion of the blood volume that is occupied by redblood cells). Any suitable hematocrit sensor, such as a CRIT-LINEmonitor from HEMA METRICS (see, HEMA METRICS, CRIT-LINE hematocritaccuracy, Vol. 1, Techn Note No. 11 (Rev. D) Feb. 24, 2003), may be usedand may serve as an indicator of blood fluid volume. A sensor configuredto monitor hemoglobin levels may also be used as an indicator of bloodfluid volume, as hemoglobin concentration is typically proportional tored blood cell concentration. Thus, lower the hemoglobin concentrationsmay be indicative of higher blood fluid volume. Any suitable sensor maybe used to measure hemoglobin concentration, such as sensors used inpulse oximeters which measure adsorption of red and infrared light todetermine concentration of oxygenated hemoglobin and deoxyhemoglobin,respectfully. The sensors (which may include the associated lightsource(s)) may be placed in any suitable location, such as around tubingthat carries blood from the patient to the blood fluid removal device orfrom the blood fluid removal device to the patient, within the bloodfluid removal device, or the like. In addition or alternatively, asensor may be implanted in a patient and disposed about a blood vesselto measure hemoglobin levels, and thus hematocrit and blood fluidlevels. By way of further example, total blood protein or albuminconcentrations and blood pressure, alone or in combination, can be usedto evaluate blood volume. High blood pressure combined with lowhematocrit or low blood protein may indicate a higher possibility ofblood fluid overloading. Alternatively or additionally, blood viscositymay be used as an indicator of blood fluid volume and may be measured bypressure or flow. Impedance, capacitance, or dialectic constant sensorsmay be employed to monitor fluid volume. For example, impedance may bemonitored between two electrodes. The electrodes may be operably coupledto control and processing electronics via leads. The electronics areconfigured to generate a voltage differential between the electrodes,current may be measured, and impedance calculated. The measurement maybe done in either DC or AC mode. Impedance or phase angle may becorrelated to tissue fluid volume. Tissue impedance sensing for purposesof monitoring tissue fluid volume has been well documented. One exampleof a well-studied system that may be used or modified for use herein isMedtronic, Inc.'s OptiVol® fluid status monitoring system. Such asystem, or other similar systems, have well-documented procedures fordetermining acceptable ranges of tissue impedance and thus fluid volume.See, e.g., (i) Siegenthalar, et al. Journal of Clinical Monitoring andComputing (2010): 24:449-451, and (ii) Wang, Am. J. Cardiology,99(Suppl):3G-1-G, May 21, 2007. Alternatively or in addition, tissueimpedance may be monitored for a suitable period of time to establish assuitable baseline, and patient markers or clinician input may be used toinstruct whether the patient is fluid overloaded or under-loaded. Thedata acquired by impedance sensor and input data regarding fluid statusof the patient at the time the sensor data is acquired may be used toestablish suitable ranges for impedance values.

Examples of sensors and systems for monitoring pH and electrolyteconcentration are disclosed in U.S. Provisional Patent Application No.61/480,532, filed on Apr. 29, 2011, entitled ELECTROLYTE AND pHMONITORING FOR FLUID REMOVAL PROCESSES and having attorney docket no.P0041418.00, which application is hereby incorporated herein byreference in its entirety to the extent that it does not conflict withthe present disclosure. Of course, any suitable sensor or systems formonitoring pH and electrolyte concentration may be used. For example, atransducer may be employed to detect pH or electrolytes. Suitabletransducers may include an ion selective electrode configured to detectH⁺ ions, K⁺ ions, Na⁺ ions, Ca²⁺ ions, Cl⁻ ions, phosphate ions,magnesium ions, acetate ions, amino acids ions, or the like. Suchelectrodes, and components of sensors employing such electrodes, areknown in the art and may be employed, or modified to be employed, foruse in the monitoring described herein. One or more sensors may beemployed to detect one or more ions to gauge pH or electrolytes in theblood. In some embodiments, a sensor may have more than one transducer,even if leadless, that may monitor more than one ionic species. Bymeasuring more than one ionic species, a more detailed understanding ofthe levels of various electrolytes or blood components may be had. Forexample, in some patients in some situations, one electrolyte may be atelevated levels while another may be at reduced levels. In someembodiments, more than one sensor for the same ion is employed forpurposes of result confirmation and redundancy, which can improvereliability and accuracy. In some embodiments, sensors for the same ionmay be configured to accurately detect different ranges ofconcentrations of the ion. In embodiments, more than one transducer ispresent in a single unit. This allows for convenient data collection andcircuitry, as all the data may be collected in one place at the sametime. Further, the multiple transducers may share the same fluidcollection mechanism (e.g., a microdialyzer in the case of an implant),and if needed or desired, may share the same data processing and memorystorage components. A sensor (or transducer) for detecting pH,electrolyte concentration, or the like may be placed at any suitablelocation for purposes of monitoring electrolytes or pH. For example, thesensor may be implanted in the patient, located external to the patientan upstream of a blood fluid removal device, located external to thepatient and downstream of the blood fluid removal device, or the like.

Examples of sensors and systems for monitoring cardiovascular parametersare disclosed in U.S. Provisional Patent Application No. 61/480,535,filed on Apr. 29, 2011, entitled CARDIOVASCULAR MONITORING FOR FLUIDREMOVAL PROCESSES and having attorney docket no. P0041857.00, whichapplication is hereby incorporated herein by reference in its entiretyto the extent that it does not conflict with the present disclosure. Ofcourse, any suitable sensor for monitoring cardiovascular parameters maybe used. In embodiments, pH or electrolyte sensors; e.g., as describedabove, may be used to monitor cardiovascular parameters. Sensors formonitoring heart rate or heart rhythm may be used. One suitableimplantable sensor device that is configured to monitor a patient's ECGsignals is a Medtronic, Inc.'s Reveal® series insertable cardiacmonitor. In embodiments, the sensor device may be a suitably equippedpacemaker or defibrillator already implanted in the patient. Monitoredcardiac signals from such a device may be transmitted to a blood fluidremoval device or intermediate device for use in the blood fluid removalsession or for setting the prescription for the blood fluid removalsession. Blood pressure monitors, which may be external or implantable(such as Medtronic Inc.'s active leadless pressure sensor (ALPS), whichgenerally takes the form of a stent to anchor the device within avessel, may be employed. Such a device may be placed in any suitableblood vessel location, such as in a femoral artery or pulmonary artery.A wearable sensor system, such as a Holter sensor system, may be used tomonitor ECG activity of the patient. Regardless of whether the sensor orsensor system employed, or components thereof, is implantable, wearable,part of a larger stand-alone device, or part of a blood fluid monitoringdevice, the sensor may monitor any suitable cardiovascular parameter ofa patient. In various embodiments, the sensors or monitoring systems areconfigured to monitor one or more of heart rate, heart rhythm or avariable thereof, or blood pressure. Examples of variables of heartrhythm that may be measured are heart rate variability (HRV), heart rateturbulence (HRT), T-wave alternans (TWA), P-wave dispersion, T-wavedispersion, Q-T interval, ventricular premature depolarization (VPD), orthe like.

As indicated above, sensors for monitoring patient physiologicalparameters may be, or may have components that are, implantable orwearable. In embodiments, multiple sensors may be connected viatelemetry, body bus, or the like. The connected sensors may be of thesame or different type (e.g., pH or impedance). Such connected sensorsmay be placed (e.g., internal or external) for purposes of monitoring atvarious locations of the patient's body.

Monitoring may occur during a blood removal session or between bloodremoval sessions. In embodiments, blood fluid removal is chronicallyperformed, such as when a blood fluid removal device or a componentthereof is wearable or implantable, and monitoring is chronicallyperformed. Chronic monitoring in association with blood fluid removal isdescribed in U.S. Provisional Patent Application No. 61/480,544, filedon Apr. 29, 2011, entitled CHRONIC pH OR ELECTROLYTE MONITORING andhaving attorney docket no. P0041857.00, which application is herebyincorporated herein by reference in its entirety to the extent that itdoes not conflict with the present disclosure.

Monitoring may alternatively or additionally include receiving patientor physician feedback regarding the patient's state. For example, thepatient may indicate a point in time when cramping begins, which oftenhappens when too much fluid is removed. The blood fluid monitoringdevice may include an input, such as a keyboard or touch screen displayfor entering such data. Alternatively, a separate device such as apatient programmer, laptop computer, tablet computer, personal dataassistance, smart phone or the like may be used to input the data; orthe like.

Any suitable system variable 530 may be adjusted. FIGS. 10-15, and theassociated text below, describe some suitable blood fluid removalsystems and variables that may be adjusted. In many cases, fluid removalrate, blood flow rate, or concentration of electrolyte or composition ofpH buffer in replacement fluid or dialysate may be adjusted. It may bedesirable to monitor blood fluid removal system parameters to ensurethat the system is performing in an expected manner. For example, it maybe desirable to monitor fluid rate removal rather than merely adjustinga system variable related to fluid removal rate to ensure that theadjusted system variable actually adjusted the fluid removal rate in theexpected manner. Any suitable system and method may be employed tomonitor such system performance. Examples of systems and methods formonitoring system performance are described in U.S. Provisional PatentApplication No. No. 61/480,541, filed on Apr. 29, 2011, entitled BLOODFLUID REMOVAL SYSTEM PERFORMANCE MONITORING and having attorney docketno. P0041858.00, which application is hereby incorporated herein byreference in its entirety to the extent that it does not conflict withthe present disclosure. For example, flow sensors such as an acousticDoppler velocimeter, an optical flow meter, a thermal flow meter, aVenturi meter, in-fluid paddle type meter, or the like may be usedupstream or downstream of blood fluid removal device to monitor systemperformance. Sensors configured to monitor an indicator of a compound inblood or in fluid removed from the blood may be used to monitor systemperformance. The sensors may be configured to monitor components ofblood that are configured to be removed during some blood fluid removalprocesses, such as hemodialysis. Examples of such compounds includeurea, creatinine, sulfate, phosphate, □-2-microglobulin, or the like.Sensors capable of measuring such compounds are known in the art and canbe readily adapted for used herein. For example, Nova Biomedicalmanufactures a variety of sensors capable of detecting components inblood such as creatinine, phosphate, urea and the like, which sensorscan be employed or adapted for use herein. Other urea sensor detectiontechnology that may be employed or adapted for used herein is describedby Zhong et al., Clin. J. Biotechnol. 1992; 8(1):57-65.□-2-microglobulin sensor detection technology that may be employed oradapted for used herein is described by Brynda et al., BiosensBioelectron. 1999; 14(4):363-8 and by Nedelkov et al., Proteomics. 2002;2(4):441-6. Of course, any suitable sensor technology may be employed.By way of further example, pressure sensors may be employed to monitorpressure differential across a blood fluid removal membrane to monitorsystem performance.

Referring now to FIG. 2, a high level flow diagram of a method isdescribed. The method includes providing input (600), such as inputvariables discussed above with regard to FIG. 1, to a blood fluidremoval system. The method also includes initiating or starting (700) ablood fluid removal session, and learning (800) from the session. Thelearning (800) may be as discussed above with regard to FIG. 1 withsystem parameters being varied and patient physiological parametersbeing monitored to determine which system parameter adjustments resultin desirable patient physiologic outcomes.

For example and with reference to FIG. 3, additional detail regarding anembodiment of a learning process that may occur during a blood fluidremoval session is shown. The blood fluid removal session is started(700) and the patient is monitored (810). Monitored patient parameters,such as patient physiological variables as discussed above, are stored(820); e.g., in memory of the blood fluid removal system. The systemparameters, such as system variables described above, which may includerate of fluid removal from the blood or electrolyte concentration of adialysate or replacement fluid, are adjusted (830) and the systemparameters are stored (840); e.g., in memory of the blood fluid removalsystem, and patient monitoring (810) continues. The set of storedpatient parameters (820) are associated (850) with a set of storedsystem parameters (840) so that the system may recall particular systemparameters that were employed at the time the patient had a given set ofparameters. The data regarding the stored patient parameters (820) andthe stored system parameters (840) may be tagged with, for example, atime event to associate the two sets of data. Of course any othersuitable method or mechanism for associating the data sets may beemployed. In some embodiments, the associated data, or a portionthereof, is placed in a lookup table tracking the patient's history ofphysiological response to changing system parameters (860).

A more detailed embodiment is presented in FIG. 4. In the embodimentdepicted in FIG. 4, patient is monitored (810) during a blood fluidremoval session. It may be desirable to determine whether data acquiredfrom patient monitoring is out of range (813). As used herein, “out ofrange” means that a value of a monitored parameter exceeds (ie., isabove or below) a predetermined range of values. The predetermined rangeof values may be indicative of a patient safety concern. If the data isout of range, an alert may be issued (815) or the session may be stopped(817). In some cases, it may be desirable to continue with the session,even if the monitored data, or some aspect thereof is out of range. Inthe depicted embodiment, if the session is continued, (e.g., due tochoice or to the monitored data not being out of range), data regardingthe monitored patient parameters is stored (820) and is compared tostored patient data previously obtained (e.g., in a prior session orearlier in the session). A determination may be made as to whether thepresent patient parameter data is less effective (823) than storedpatient parameter data resulting from system parameter adjustments (830)that occurred just prior to the current set of system parameters. If thedata is determined to be less effective (823), the stored currentpatient parameters (820) may be associated (851) with stored currentsystem parameters (840); e.g., as discussed above. In some cases, it maybe desirable to determine whether the current patient parameter data, ora portion or aspect thereof, is the least effective that has beendetected in the patient in a current or previous blood fluid removalsession (825); e.g. by comparing the current patient data to a historyof collected patient data. If the current patient data is the leasteffective observed (825) to date, the stored current patient parameters(820) may be associated (851) with stored current system parameters(840). In this way, only the “least effective” patient conditions aretracked, as opposed to all patient conditions, which can save on memoryand processing power. In any case, once the patient and system parameterdata is associated (851), the system parameters may be adjusted (830)and the process repeated.

If the present patient parameter data is determined to not be lesseffective than stored patient parameter data resulting from systemparameter adjustments that occurred just prior to the current set ofsystem parameters, a determination may be made as to whether the presentpatient parameter data is more effective (833) than stored patientparameter data resulting from system parameter adjustments (830) thatoccurred just prior to the current set of system parameters. If the datais determined to be more effective (833), the stored current patientparameters (820) may be associated (852) with stored current systemparameters (840); e.g., as discussed above. In some cases, it may bedesirable to determine whether the current patient parameter data, or aportion or aspect thereof, is the most effective that has been detectedin the patient in a current or previous blood fluid removal session(835); e.g. by comparing the current patient data to a history ofcollected patient data (e.g., “history table” in FIG. 3). If the currentpatient data is the most effective observed (835) to date, the storedcurrent patient parameters (820) may be associated (852) with storedcurrent system parameters (840). In this way, only the “best” or mosteffective patient conditions are tracked, as opposed to all patientconditions, which can save on memory and processing power. In any case,once the patient and system parameter data is associated (852), thesystem parameters may be adjusted (830) and the process repeated.

Referring now to FIG. 5, an embodiment of a method where more than onepatient parameter variable is evaluated in a manner similar to thatdescribed with regard to FIG. 4. In the embodiment depicted in FIG. 5,two patient parameter variables are evaluated. However, it will beunderstood that any number of patient parameter variables may beevaluated by employing a method as depicted in FIG. 5 or using any othersuitable method. In the embodiment depicted in FIG. 5, the variables arelabeled “primary” and “secondary”, as it may be desirable to prioritizepatient parameter variables. For example, in some cases it may bedesirable to monitor blood pressure and attempt to achieve a stableblood pressure at or near a target range throughout the session becausehypotension is one of the most common side effects of blood fluidremoval sessions. That is, as long as other patient parameters are notout of a pre-determined range, the system may attempt to keep bloodpressure in check and make adjustments to that end. However, in somecases, reducing arrhythmias is the primary goal, as many patients forwhich a blood fluid removal process is indicated dire from complicationsdue to arrhythmias. If arrhythmias are determined to be the primarypatient parameter, the blood fluid removal system may attempt to keeparrhythmias in check and make adjustments to this effect without regardto other patient parameters, e.g., as long as the other patientparameters remain within acceptable limits.

The method depicted FIG. 5 includes monitoring patient parameters (810)(at least a primary and secondary patient parameter), storing patientparameter data (820), and determining whether a parameter, or aspectthereof, is out of a predetermined range (813). If the parameter is outof range, an alert may be issued (815), the blood fluid removal sessionmay be stopped (817) or the session may continue. If the parameters aredetermined to not be out of range (813), the system parameters may beadjusted (843) and stored (840). A determination may then be made as towhether the primary patient parameter is less effective (843), e.g. bycomparing current patient parameter data to stored patient parameterdata resulting from system parameter adjustments that occurred justprior to the current set of system parameters. If the primary patientparameter is determined to be less effective (843), the current storedpatient parameter data may be associated (853) with the current storedsystem parameters. Alternatively or in addition, a determination may bemade as to whether the current patient parameter data regarding theprimary parameter is the lease effective that has been detected in thepatient in a current or previous blood fluid removal session (845);e.g., as discussed above with regard to FIG. 4. If it is the leasteffective, the current stored patient parameter data may be associated(853) with the current stored system parameters as described above withregard to FIG. 4. Similarly determinations as to whether the primarypatent parameter data is more effective (853) or the most effective todate (855) may be made and stored system and patient parameters may beassociated (854). Similar determinations regarding whether the secondarypatient parameter, or a value associated therewith, is less effective(863), the least effective (865), more effective (873), the mosteffective (875) and appropriate associations (855, 856) may be made. Inthis manner, the system may identify and learn how system parameters mayaffect individually monitored patient parameters, such as bloodpressure, heart rate, fluid volume, and electrolyte concentration. Basedon this information, the system may make choices as to which systemparameters may be employed to produce results that are likely to befavorable to the patient.

Referring now to FIG. 6, a flow diagram depicting a process where thecombined response of two or more patient parameters to changes in systemparameters (830) is tracked. For the purposes of convenience some of thesteps depicted and described above with regard to FIGS. 4-5 are omittedfrom FIG. 6. However, it will be understood that the same or similarsteps may be employed with regard to the method depicted in FIG. 6. Inthe depicted embodiment, patient parameters and system parameters arestored (857, 858) only when both the primary and secondary patientparameters are determined to become less effective (843, 863) or moreeffective (853,873). In this manner, the system may identify or learnwhich system parameters result in desirable (or undesirable) changes inmultiple patient parameters.

Through the association of patient parameter data and system parameterdata as shown in FIGS. 3-6 and discussed above, a history of patientresponses to changing system parameters may be obtained. This history,which may be in the form of a lookup table, may be consulted prior to orduring a blood fluid removal session to determine which systemparameters, given the patient's physiological parameters at a givenpoint in time, are more likely to cause the patient to respond favorablyand which system parameters are more likely to cause the patient torespond negatively. Accordingly, the system may respond by adjustingparameters to those that are more likely to cause the patient to respondfavorably.

For example and with reference to FIG. 7, a flow diagram is shown thatdepicts and embodiment of how stored and associated data (e.g., asdiscussed above with regard to FIGS. 3-6) may be used to determine whichsystem parameters to use at a given time in a blood fluid removalsession. The method includes initiating or starting a blood fluidremoval session (700), monitoring patient parameters (810), andconsulting history lookup table (880), which may be generated byassociating system parameters and patient parameters as described abovewith regard to FIGS. 3-6. A value associated with the current patientparameter data is compared to data regarding a corresponding value inthe lookup table, and a determination is made as to whether the currentpatient parameter is similar to prior patient parameter data stored inthe history table (882). By way of example, a value of a current patientparameter data set may be determined to be similar to a correspondingvalue in the lookup table if the values are within 10%. The system mayscroll through the lookup table to identify the closest correspondingvalue, if more than one corresponding value is within the predeterminedcutoff for being considered similar (e.g., within 10%). As used herein,a “corresponding” value is a value of the same parameter obtained atdifferent times. The value may be a magnitude, a rate of change, anaverage, or the like. The parameter may be blood pressure, heart rate,fluid volume, concentration of electrolyte, or the like.

If more than one parameter or value of a parameter is compared to datain the lookup table, the system may determine whether each value foreach parameter is within the predetermined cutoff for being consideredsimilar and identify a prior patient parameter data set as being mostsimilar by prioritizing or weighting parameters or by summing thepercent differences between all of the current values and thecorresponding values in the lookup table. Regardless of how the systemdetermines whether a current patient parameter data set is similar, ormost similar, to a prior patient data set stored in the history table, adetermination may be made as to whether the patient's response to thesystem parameters associated with the stored patient parameter datatable was a favorable response (884); e.g., was “better” (or “moreeffective”) or “best” (or “most effective”) as discussed above withregard to FIGS. 4-6. If the prior patient response was determined to bea good or “effective” response, the current system parameters may be setaccording to the parameters stored in the lookup table (892). If theprior patient response was considered to not to be similar (882) oreffective (884), a default table may be consulted (888) which containsnon-patient specific system parameters that would generally beconsidered suitable in general circumstances or that would be consideredsuitable for a patient presenting with the current physiologicalparameters. The system parameters may then be set according to theparameters stored in the default table (890).

It will be understood that prior patient negative responses (e.g., “lesseffective”, “least effective”) may be stored in a lookup table, accessedand used in a similar manner to that described with regard to the“effective” responses in FIG. 7. In some embodiments, separate lookuptables are maintained for “effective” responses (e.g., an “increasedeffectiveness” data table) and for “ineffective responses” (e.g., a“decreased effectiveness” data table). In some embodiments, the“increased effectiveness” lookup table and the “decreased effectiveness”lookup table are the same data table, which stores patient parametersand associated system parameters that resulted in “more effective”,“most effective”, “less effective” or “least effective” patientparameters.

For purposes of example and to provide some clarity with regard to howone (or a blood fluid removal system) may determine whether patientparameter data is “out of range”, “more effective”, “less effective”,and the like (as discussed above with regard to FIGS. 4-6), graphicalschematic data is presented in FIG. 8 showing representations ofmonitored data (not actual data) for blood pressure (BP), heart rate(HR), and potassium concentration in the patient's blood ([K⁺]). In theschematic illustration, system parameters are changed at times T1, T2,T3 and T4. The patient parameters (BP, HR, [K⁺]) are shown as changingin response to the changes in blood fluid removal system parameters. Asshown, not all patient parameters will respond similarly (e.g., moreeffective or less effective) in response to a system parameter change.In the depicted schematic illustrations, a desired target value is shownfor each patient parameter. If the monitored data value achieves orapproaches the target, a determination may be made that the change insystem parameter resulted in an improvement or “more effective” statefor that parameter. If the monitored data value deviates from thetarget, a determination may be made that the change in system parameterresulted in a worsening or “less effective” state for that parameter. Itwill be understood that the timing of the patient parameter response toa change in system parameters may vary greatly from patient parameter topatient parameter. In some cases, changes in a patient parameter may beobserved within seconds or minutes of a change in a system parameter. Inother cases, a change in a patient parameter in response to a change ina system parameter may take hours or more to be fully appreciated orobserved.

In the graphical depictions of the represented monitored data presentedin FIG. 8, a lower threshold value and an upper threshold value aredepicted by horizontal dashed lines. If the monitored data for a patientparameter exceeds the upper threshold value or crosses below the lowerthreshold value, a determination may be made that the value for thatparameter is “out of range.”

It will be understood that the condition of a patient may deterioratewith time, which is typical of patients having chronic kidney disease.Accordingly, the targets and upper and lower thresholds may vary withtime. These targets and thresholds may be modified by input from, forexample, a healthcare provider from time to time based on, e.g., thepatient's health or status of patient parameters. Alternatively, thesystem may automatically adjust target or threshold values over timebased on population data or based on data of a particular patientindicative of a generally deteriorating condition. If the target orthresholds are adjusted to or near predetermined cutoff values, an alertmay be issued to that effect.

Further, target and threshold values for one or more parameters may bemodified on a session-by-session basis. For example, if the patient isexcessively fluid overloaded prior to a given session, the target orthreshold tissue fluid levels may be adjusted upward for the next orcurrent session. The negative consequences of too much fluid removal inone session or at too fast of a rate may outweigh the negativeconsequences of higher fluid levels remaining in the patient. Additionalor more frequent fluid removal sessions may be employed to return thepatient to more desirable fluid levels.

As shown in the examples presented in FIG. 8, the patient parameterschange over time. In embodiments, values of one or more patientparameters are averaged over a period of time to account forfluctuations that may occur. The averaged value may be compared to thetarget and thresholds for determining whether a patient is improving. Byaveraging values over time, the effect of an anomalous value that maydeviate significantly from the target value or may be out of bounds maybe diminished. Of course, thresholds may be set for single occurrences,for example if the values of those occurrences may present an imminenthealth concern to the patient. In embodiments, the presence a singleoccurrence that deviates significantly from other recent occurrences mayresult in activation of a subroutine or monitoring method for detectingsimilar subsequent deviations. In embodiments, consecutive significantdeviations, a percent of significant deviations within a given number ofsamples, or the like, may result in activation or an alert or alarm.

In embodiments, patient parameters are measured or monitored withindiscrete windows of time rather than continuously. Such time samplingmay be valuable for implantable systems or systems having implantablecomponents as the power and processing requirements may be reducedrelative to continuous monitoring.

The discussion with regard to FIGS. 3-8 has been primarily directed toblood fluid removal systems and processes that may occur during a bloodfluid removal session for associating system parameter data and patientparameter data to enhance the blood fluid removal session or to tailorthe blood fluid removal treatments to render the treatmentpatient-specific. It will be understood that any suitable method orprocess may be employed to achieve such results, and such methods orprocesses are contemplated for use herein. It will be further understoodthat similar methods or processes may be employed to enhance or tailorsystem parameters prior to initiating a blood fluid removal session sothat patient-specific parameters may be set at the beginning of asession.

For example and with reference to FIG. 9, a flow diagram depicting amethod that may be employed to determine which system parameters toselect at the beginning of a blood fluid removal session is shown. Thedepicted method is similar in many respects to the method depicted inFIG. 7. In FIG. 9, the method includes receiving, inputting or obtainingpatient or physician input (900) and patient physiological parameters(910). As discussed above with regard to FIG. 1, physician or patientinput may include how long since the patient's last blood fluid removalsession, how long does the patient have for the given blood fluidremoval session and the like. In some embodiments, system generatedinput is provided based on data collected during the last session.Patient physiological parameters may be similar to those describedabove. A history lookup table may be consulted (920), and adetermination may be made as to whether the patient has previously cometo a blood fluid removal session in a similar state (930) based on thepatient or physician input, the patient's physiological parameters, orother input. If a determination is made that the patient has come toprevious blood fluid removal session in a similar state (930), whichdecision may be made generally as described above with regard to FIG. 7,a determination may be made as to whether system parameters were used insuch a previous session to which the patient responded to favorably orhad an “effective” response (940). If the patient is determined to havehad an effective response, then the initial system parameters may be setin accordance with the parameters stored in the history table (950). Ifthe patient is determined to not have come to a blood fluid removalsession in a similar state (930) or to not have had an effectiveresponse (940), then a default table (e.g., similar to as describedabove with regard to FIG. 7) may be consulted (960) and the initialsystem parameters may be set according to the parameters in the defaulttable (970).

It will be understood that the processes, and components thereof,described above with regard to FIGS. 1-7 and 9 are provided for purposesof illustration and not limitation. Process steps other than thosedescribed herein, or derivations of the steps or components to carry outthe steps, may be employed. Further, process steps depicted anddiscussed above may be interchanged, substituted, added to, or omittedfrom processes of alternative embodiments, as appropriate.

The processes described above may be employed with any suitable deviceor system for removing fluid, or fluid and contaminants, from blood. Thedevices, or components thereof, may be traditional large counsel-type,wearable, or implantable.

Block diagrams of some example devices and systems are shown in FIGS.10-12. As shown in FIG. 10, blood may be removed from a patient 10 andfluid may be removed via a blood fluid removal device 100 and returnedto the patient 10. Removed fluid may be diverted. In some embodimentswhere the blood fluid removal device 100 or system, or componentsthereof, are implanted, the removed fluid may be diverted to thepatient's bladder. Examples of blood fluid removal devices 100 that mayoperate as depicted in FIG. 10 are ultrafiltration and hemofiltrationdevices. Examples of such devices and components thereof that may beemployed in accordance with the teachings presented herein are wellknown in the art. With some of such devices, replacement fluid may beintroduced into the patient's blood if fluid is removed from the bloodby the device 100 at too great of a rate or amount. The replacementfluid may be added to the original blood before fluid removal or may beadded to the blood after initial fluid removal and prior to return tothe patient's cardiovascular system. Preferably, the replacement fluidis added after initial fluid removal. The pH and electrolyteconcentration of the replacement fluid may be set or adjusted, e.g. asdescribed in more detail below.

As shown in the embodiment depicted in FIG. 11, the blood fluid removaldevice 100 may employ dialysate to assist in removal of contaminantsfrom the patient's blood and in maintaining proper pH and electrolytebalance. The pH or electrolyte concentration of the dialysate may be setor adjusted, e.g. as described in more detail below. Used dialysate andfluid removed from the blood may be diverted. In some embodiments,particularly where the blood fluid removal device 100 or system orcomponents thereof are wearable or implantable, the used dialysate andremoved fluid, or a portion thereof, may be regenerated (indicated bydashed lined regeneration system 150) to produce fresh dialysate forre-use in the blood fluid removal process. One system for regenerationof dialysate is the REDY system, such as described in Roberts, M, “Theregenerative dialysis (REDY) sorbent system,” Nephrology 4:275-278,1998, which system may be employed or readily modified for use inembodiments described herein. As shown in FIG. 11, a concentrate may beadded to the regenerated dialysate to adjust the pH and electrolytes ofthe regenerated dialysate to an amount suitable for re-use as freshdialysate.

Regardless of whether the dialysate is regenerated, systems and devicesthat operate in a manner shown in the embodiment of FIG. 11 includehemodialysis and hemodiafiltration systems. Examples of such devices andcomponents thereof that may be employed in accordance with the teachingspresented herein are well known in the art. It will be understood thatperitoneal dialysis, where the dialysate is introduced into peritonealcavity may also be employed.

As shown in FIG. 12, in cases where the blood fluid removal device 100of FIG. 11 removes fluid from the blood at too high of a rate,replacement fluid may be introduced into the patient's blood, upstreamor downstream of fluid removal, e.g. as described above with regard toFIG. 10.

Regardless of the device or blood fluid removal process employed, systemparameters such as rate of fluid removal, blood flow rate or electrolyteor pH buffer component or concentration may be controlled. Someschematic block diagrams for controlling electrolyte or pH of adialysate or replacement fluid (and thus of blood) are shown in FIG. 13,in which representative components of an example of a closed-loop systemfor adjusting pH and electrolyte concentrations of fluid are shown.

With reference to FIG. 13, input data 600 (e.g. input 600 as discussedabove with regard to FIG. 2) or “learned” parameters may be presentedto, or processed within, control electronics 495, which are configuredto control flow control elements 415, 425, 435, such as valves. Theelectronically controllable flow control elements 415, 425, 435 are influid communication with supplies of concentrated electrolyte or buffersolutions 410, 420, 430 and with fluid line 440, which may be a catheterfor carrying fresh dialysate or a catheter for carrying replacementfluid. The electronically controllable flow control elements 415, 425,435, via control electronics 495, control the rate at which theconcentrates 410, 420, 430 flow into the fluid line 440. Theconcentrates 410, 420, 430 are added to bulk fluid 400 to adjust theconcentration of electrolytes or the pH of the bulk fluid (and thus theblood).

Any number of suitable concentrates may be used. For example, oneconcentrate may be sufficient with higher amounts being added when theelectrolytes are determined to be low in the patient's blood, andsmaller amounts being added when the electrolytes are determined to behigh in the patient's blood. More than one concentrate may be used whenit is desired to, for example, control pH and electrolyte concentrationindependently or to control concentration of different electrolytesindependently.

Control elements 415, 425, 435, as depicted in FIG. 13 and discussedabove, may be any suitable control element, such as electronicallycontrollable valves, electronically controllable pump mechanisms, or thelike.

Any suitable system may be configured as depicted in FIG. 13 to providecontrol of adjustment of pH or electrolytes based on input data 600 or“learned” parameters. By way of example, selected components of twoexample systems are illustrated in FIGS. 14-15.

Referring now to FIG. 14, the depicted device 100 includes a fluidpathway for adding replacement fluid to blood before it is returned tothe patient. The device 100 includes an inlet 110 for receiving bloodfrom the patient and an outlet 140 for returning blood to the patient.In the flow path between the inlet 110 and outlet 140 are a blood flowcontrol element 120 and a medium for removing fluid and contaminantsfrom the blood. The blood flow control element 120 is operably coupledto control electronics 150 which provide instructions to control therate at which blood is passed through medium 130. Fluids andcontaminants removed from the blood by the medium 130 may exit viaoutlet 180.

The device 100 depicted in FIG. 14 also includes an inlet 197 forreceiving bulk replacement fluid and a replacement fluid flow controlelement 195 in communication with the inlet and configured to controlthe rate at which the replacement fluid is added to the blood. Thecontrol electronics 150 are operably coupled to the replacement fluidflow control element 195 and are configured to control the rate at whichreplacement fluid flow control element 195 adds fluid to the blood. Thedevice 100 also includes (i) an inlet 401 for receiving a concentratefor adjusting the pH or electrolyte concentration of the bulkreplacement fluid, and (ii) a concentrate flow control element 415 incommunication with the inlet 401 and configured to control the rate atwhich the concentrate is added to the replacement fluid or blood beforethe blood is returned to the patient. Preferably, the concentrate isadded to the replacement fluid prior to the replacement fluid beingadded to the blood (as depicted) so that the concentrate may be mixed ordiluted prior to being added to the blood. The device may include amixer (not shown) to mix the concentrate and bulk replacement fluidprior to adding to the blood.

In the device depicted in FIG. 14, the control electronics 150 areoperably coupled to the concentrate flow control element 415 and areconfigured to control the rate at which the concentrate flow controlelement 415 adds fluid to the replacement fluid or blood. By controllingthe rate at which the concentrate is introduced into replacement fluidor blood, the concentration or pH (or buffering capacity) of thereturned blood can be controlled.

Referring now to FIG. 15, in which components that are numbered the sameas in FIG. 14 refer to the same or similar components, a schematic blockdiagram of selected components of a blood fluid removal device 100 isshown. In the embodiment depicted in FIG. 15, the device has in inlet110 for receiving blood from a patient, a blood flow control element 120in communication with the inlet 110 and configured to control the rateat which blood flows through medium 130 for removing fluid andcontaminates from the blood. The device also includes an outlet 140 incommunication with the medium 130 for returning blood to the patient. Inthe depicted embodiment, the medium 130 includes a semipermeable filter135, such as a hemodialysis or hemodiafiltration filter. The membraneseparates a blood flow compartment from a dialysis flow compartment ofthe medium component 130.

In the embodiment depicted in FIG. 15, used dialysate is regenerated bypassing through dialysate regeneration medium 402 or components, suchREDY regeneration medium and components, or the like, to regenerate bulkdialysate. The device also has an outlet 180 in communication with themedium 130 for diverting fluid removed from the blood out of the device.A flow regulator element 700, such as a valve, is operably coupled tocontrol electronics 150 and is disposed in the flow path between themedium 130 and the outlet 180 to control the amount of fluid that exitsthe device (as a portion of the fluid is regenerated). Often, theregeneration media or components (402) remove much of the pH buffer orelectrolytes from the dialysate. Accordingly, a concentrate containingconcentrated electrolytes and pH buffers is added to the regenerateddialysate before the dialysate re-enters the medium 130. In someembodiments, a sensor 299 is positioned downstream of the regenerationmedium 402 to monitor a level of a component of the regenerateddialysate. The sensor 299 may be a pH or electrolyte sensor and dataacquired from sensor 299 may be used in determining how much concentrateto add to the regenerated fluid (which data may be provided to controlelectronics 150). The sensor 299 may be a sensor that monitors a bloodwaste product, such as urea, to determine whether the regeneration media402 is properly functioning. Increased or detectable levels of a wasteproduct may indicate that the regeneration media 402 or components mayneed replacement or regeneration.

In the depicted embodiment, the concentrate 410 is stored in a reservoir410, having an inlet 401 that allows the concentrate supply in thereservoir 410 to be replenished from time to time. The rate at which theconcentrate is added to the regenerated dialysate is controlled byconcentrate flow control element 415, which is operably coupled tocontrol electronics 150, and may be based on input data 600 or “learned”parameters as described above.

The device 100 in FIG. 15 also has a dialysis flow control element 170for controlling the rate at which dialysis is introduced into thedialysis flow compartment of the medium 130.

In the depicted embodiment, the device 100 also includes a negativepressure control element 190 in communication with the dialysatecompartment of the medium component 130. The negative pressure controlelement 190, which may include a vacuum pump or the like, may be used togenerate or change a pressure differential across the membrane tocontrol the rate at which fluid is removed from blood that passes thoughthe medium component 130.

The control electronics 150, which may include a processor, memory,etc., are operably coupled to, and configured to control, the blood flowcontrol element 120, the dialysis flow control element 170, and thenegative pressure control element 190. By controlling these elements ina coordinated manner, the rate at which fluid is removed from blood maybe controlled. It will be understood that a device 100 need not have allof the controllable elements (120, 170, 190) depicted in FIG. 15 toeffectively control rate of fluid removal from blood.

Any suitable control element may be used for the various controlelements (120, 150, 170, 195, 415) depicted in FIGS. 14-15. For example,a variable or adjustable rate pump may be employed. Alternatively or inaddition, a series of electronically controllable valves may beemployed. In some embodiments, the valves are in communication flowpaths having differing flow resistances.

While FIGS. 14-15 depict components as being within a single unit, itwill be understood that one or more of the components may be housed inseparate units. For example, the control electronics, or a portionthereof, may be housed in a separate device, such as a computer, tablet,physician programmer, or the like. The computer, tablet, etc. mayreceive input from sensors, determine appropriate action to take, andinstruct appropriate components of a blood fluid removal device to takethe appropriate action.

It will be understood that the blood fluid removal devices and systems,and components thereof, described herein are presented for purposes ofillustration and not limitation. Components, devices and systems otherthan those described herein, or derivations of the components, devicesand systems described herein, may be employed. Further, components ofthe devices depicted and discussed above may be interchanged,substituted or added to components of alternative embodiments, asappropriate. Further, it will be understood that, while many of theblood fluid removal devices depicted in a variety of the figures, suchas FIGS. 10-12, are shown as external to the patient, the teachingspresented herein apply if the device, or components thereof, wereimplanted in the patient.

The devices and systems described above, or components thereof, may beused to carry out the methods depicted in FIGS. 1-7 and 9, or portionsthereof. Of course, any suitable device or system may be employed tocarry out the methods, or portions thereof, described above.

The methods described herein, including the methods depicted in FIGS.1-7 and 9, may be carried out by blood fluid removal devices or systems,or other devices in communication with blood fluid removal devices orsystems. These methods may be algorithms or instructions programmed intomemory of such devices, which may be carried out by processors or othercontrol electronics of the devices. Preferably, the processor is incommunication with appropriate control elements of the devices and isconfigured to control such elements in a manner such that the programmedinstructions are carried out by the appropriate device. It will beunderstood that a computer readable medium programmed with instructionsthat cause a sensor device, blood fluid removal device, or othersuitable device to carry out a method, or a portion thereof, asdescribed herein are contemplated. The computer readable medium may benon-transitory, i.e. lasting for more than a fleeting instant orseconds. The medium may be memory, such as RAM or ROM, a cd or dvd,flash memory, or the like.

Various aspects of methods, devices, systems, computer-readable media,and the like are described herein. A summary of some of selected aspectsdescribed herein is presented below.

In a first aspect, a method carried out by a blood fluid removal system,comprises (a) initiating a blood fluid removal session with initialsystem parameters; (b) acquiring a first set of data regarding one ormore patient physiological parameters; (c) storing the first data set ina most effective to date data set memory; (d) associating the initialsystem parameters in an increased effectiveness lookup table with thefirst data set; (e) adjusting at least one parameter of the blood fluidremoval session to arrive at adjusted system parameters; (f) acquiring asecond set of data regarding the one or more patient physiologicalparameters after the at least one parameter of the blood fluid removalsession has been adjusted; and if at least one value of the second dataset is closer to the target value than a corresponding at least onevalue of the first data set: replacing the first data set in the mosteffective to date data set memory with the second data set; storing inthe increased effectiveness lookup table data regarding the second dataset; and associating data regarding the adjusted system parameters withthe second data set.

A second aspect is a method of the first aspect, further comprising (a)storing the first data set in a least effective to date data set memory;(b) associating the initial system parameters in a decreasedeffectiveness lookup table with the first data set prior to adjustingthe at least one parameter of the blood fluid removal session; and (c)if the at least one value of the second data set is not closer to thetarget value than the corresponding at least one value of the first dataset: replacing the first data set in the least effective to date dataset memory with the second data set; storing in the decreasedeffectiveness lookup table data regarding the second data set; andassociating data regarding the adjusted system parameters with thesecond data set.

A third aspect is a method of the first or second aspect, furthercomprising (a) further adjusting at least one parameter of the bloodfluid removal session to arrive at further adjusted system parameters;(b) acquiring a third set of data regarding the one or more patientphysiological parameters after the at least one parameter of the bloodfluid removal session has been further adjusted; and (c) if at least onevalue of the third data set is closer to the target value than acorresponding at least one value stored in the most effective to datedata set memory: replacing the data set in the most effective to datedata set memory with the third data set; and storing in the increasedeffectiveness lookup table data regarding the third data set andassociating data regarding the further adjusted system parameters withthe third data set.

A fourth aspect is a method of the second aspect, further comprising (a)further adjusting at least one parameter of the blood fluid removalsession to arrive at further adjusted system parameters; (b) acquiring afourth set of data regarding the one or more patient physiologicalparameters after the at least one parameter of the blood fluid removalsession has been further adjusted; and (c) if at least one value of thefourth data set is not closer to the target value than a correspondingat least one value stored in the least effective to date data setmemory: replacing the data set in the least effective to date data setmemory with the fourth data set; and storing in the decreasedeffectiveness lookup table data regarding the fourth data set andassociating data regarding the further adjusted system parameters withthe fourth data set.

A fifth aspect is a method of any of aspects 1-4, further comprising (a)acquiring a fifth set of data regarding one or more patientphysiological parameters; (b) comparing the fifth data set to theincreased effectiveness lookup table; and (c) adjusting the systemparameters the system parameters associated with the data set stored inthe increased effectiveness lookup table if at least one parameter of adata set stored in the increased effectiveness lookup table is within apredetermined range of the fifth data set.

A sixth aspect is a method of any of aspects 1-5, further comprising (a)stopping the blood fluid removal session; (b) acquiring a sixth set ofdata regarding one or more patient physiological parameters; (c)comparing the sixth data set to the increased effectiveness lookuptable; and (d) initiating a second blood fluid removal session with thesystem parameters associated with the data set stored in the increasedeffectiveness lookup table if at least one parameter of a data setstored in the increased effectiveness lookup table is within apredetermined range of at least one parameter of the sixth data set.

A seventh aspect is a method of any of aspects 1-6, wherein the at leastone of the one or more patient parameters are selected from the groupconsisting of blood pressure, heart rate, pH and concentration of anelectrolyte.

An eighth aspect is a method of the seventh aspect, wherein theelectrolyte is potassium.

A ninth aspect is a method of any of aspects 1-7, wherein the systemparameters comprise one or more of fluid removal rate and concentrationof one or more electrolyte.

A tenth aspect is a blood fluid removal system, comprising (a) a bloodfluid removal medium configured to remove blood from a patient, whereinblood enters the medium, fluid is removed from the blood, and bloodexits the medium; (b) one or more control elements configured to control(i) the rate at which the medium removed fluid from the blood or (ii)the concentration of electrolytes or pH in the blood that exits themedium; (c) one or more sensors configured monitor one or morephysiological parameter of the patient; and (e) control electronicscomprising memory and a processor, wherein the control electronics arein operable communication with the one or more sensors and are operablycoupled to the one or more control elements, wherein the controlelectronics are configured to carry out a method according to any ofaspects 1-9.

An eleventh aspect is a system of the tenth aspect, wherein the bloodfluid removal medium and the control electronics are housed within ablood fluid removal device.

A twelfth aspect is a system of aspect 10 of 11, further comprising acomputer readable, wherein the computer readable medium comprisesinstructions that cause the control electronics to carry out the methodaccording to any of claims 1-9.

A thirteenth aspect is a blood fluid removal system comprising: (a) ablood fluid removal medium configured to remove blood from a patient,wherein blood enters the medium, fluid is removed from the blood, andblood exits the medium; (b) one or more control elements configured tocontrol (i) the rate at which the medium removed fluid from the blood or(ii) the concentration of electrolytes or pH in the blood that exits themedium; (c) one or more sensors configured monitor one or morephysiological parameter of the patient; and (d) control electronicscomprising memory and a processor, wherein the control electronics arein operable communication with the one or more sensors and are operablycoupled to the one or more control elements, wherein the controlelectronics are configured to (i) initiate a blood fluid removal sessionwith initial system parameters; (ii) acquire a first set of dataregarding one or more patient physiological parameters; (iii) store thefirst data set in a most effective to date data set memory; (iv)associate the initial system parameters in an increased effectivenesslookup table with the first data set; (v) adjust at least one parameterof the blood fluid removal session to arrive at adjusted systemparameters; (vi) acquire a second set of data regarding the one or morepatient physiological parameters after the at least one parameter of theblood fluid removal session has been adjusted; and (vii) if at least onevalue of the second data set is closer to the target value than acorresponding at least one value of the first data set: replace thefirst data set in the most effective to date data set memory with thesecond data set; store in the increased effectiveness lookup table dataregarding the second data set; and associate data regarding the adjustedsystem parameters with the second data set.

A fourteenth aspect is a computer-readable medium comprisinginstructions that, when executed by a blood fluid removal device, causethe device to (a) initiate a blood fluid removal session with initialsystem parameters; (b) acquire a first set of data regarding one or morepatient physiological parameters; store the first data set in a mosteffective to date data set memory; (c) associate the initial systemparameters in an increased effectiveness lookup table with the firstdata set; (d) adjust at least one parameter of the blood fluid removalsession to arrive at adjusted system parameters; (e) acquire a secondset of data regarding the one or more patient physiological parametersafter the at least one parameter of the blood fluid removal session hasbeen adjusted; and (f) if a at least one value of the second data set iscloser to the target value than a corresponding at least one value ofthe first data set: replace the first data set in the most effective todate data set memory with the second data set; store in the increasedeffectiveness lookup table data regarding the second data set; andassociate data regarding the adjusted system parameters with the seconddata set.

A fifteenth aspect is a method carried out by a blood fluid removalsystem, comprising: (a) acquiring data regarding one or more of: (i) oneor more patient physiological parameters; and (ii) time since last bloodfluid removal session; (b) acquiring data regarding one or more targetoutcomes of a blood fluid removal session; (c) determining whether atleast one of the one or more target outcomes is within a predeterminedrange of a at least one corresponding prior target outcome stored in alookup table, wherein the lookup table comprises data regarding systemparameters used in one or more prior blood fluid removal sessions of thepatient; (d) determining whether the at least one target outcome wasachieved with the system parameters used in the prior blood fluidremoval session; (e) if the at least one target outcome is determined tohave been achieved, determining whether at least one of the patientparameters or time since last blood fluid removal session is within apredetermined range of at least one corresponding parameter stored inthe lookup table; and (f) initiating a blood fluid removal sessionemploying the system parameters used the prior blood fluid removalsession if the at least one patient parameter or time since last bloodfluid removal session is determined to be within a predetermined range.

A sixteenth aspect is a method of the fifteenth aspect, wherein the atleast one of the one or more patient parameters are selected from thegroup consisting of blood pressure, heart rate, pH and concentration ofan electrolyte.

A seventeenth aspect is a method of the sixteenth aspect, wherein theelectrolyte is potassium.

An eighteenth aspect is a method of any of aspects 15-17, wherein thesystem parameters comprise one or more of fluid removal rate andconcentration of one or more electrolyte.

A nineteenth aspects is a blood fluid removal system, comprising: (a) ablood fluid removal medium configured to remove blood from a patient,wherein blood enters the medium, fluid is removed from the blood, andblood exits the medium; (b) one or more control elements configured tocontrol (i) the rate at which the medium removed fluid from the blood or(ii) the concentration of electrolytes or pH in the blood that exits themedium; (c) one or more sensors configured monitor one or morephysiological parameter of the patient; (d) an input configured to allowentry of data regarding patient or system parameters; and (e) controlelectronics comprising memory and a processor, wherein the controlelectronics are in operable communication with the one or more sensorsand are operably coupled to the one or more control elements and theinput, wherein the control electronics are configured to carry out amethod according to any of aspects 15-18.

A twentieth aspect is a system of the nineteenth aspect, wherein theblood fluid removal medium and the control electronics are housed withina blood fluid removal device.

A twenty-first aspect is a system of aspect 19 or 20, further comprisinga computer readable, wherein the computer readable medium comprisesinstructions that cause the control electronics to carry out the methodaccording to any of aspects 15-18.

A twenty-second aspect is a blood fluid removal system comprising: (a) ablood fluid removal medium configured to remove blood from a patient,wherein blood enters the medium, fluid is removed from the blood, andblood exits the medium; (b) one or more control elements configured tocontrol (i) the rate at which the medium removed fluid from the blood or(ii) the concentration of electrolytes or pH in the blood that exits themedium; (c) one or more sensors configured monitor one or morephysiological parameter of the patient; (d) an input configured to allowentry of data regarding patient or system parameters; and (e) controlelectronics comprising memory and a processor, wherein the controlelectronics are in operable communication with the one or more sensorsand are operably coupled to the one or more control elements and theinput, wherein the control electronics are configured to: (i) acquiredata regarding one or more of: one or more patient physiologicalparameters; and time since last blood fluid removal session; (ii)acquire data regarding one or more target outcomes of a blood fluidremoval session; (iii) determine whether at least one of the one or moretarget outcomes is within a predetermined range of a at least onecorresponding prior target outcome stored in a lookup table, wherein thelookup table comprises data regarding system parameters used in one ormore prior blood fluid removal sessions of the patient; (iv) determinewhether the at least one target outcome was achieved with the systemparameters used in the prior blood fluid removal session; (v) if the atleast one target outcome is determined to have been achieved, determinewhether at least one of the patient parameters or time since last bloodfluid removal session is within a predetermined range of at least onecorresponding parameter stored in the lookup table; and (vi) initiate ablood fluid removal session employing the system parameters used theprior blood fluid removal session if the at least one patient parameteror time since last blood fluid removal session is determined to bewithin a predetermined range.

A twenty-third aspect is a computer-readable medium comprisinginstructions that, when executed by a blood fluid removal device, causethe device to (a) acquire data regarding one or more of: one or morepatient physiological parameters; and time since last blood fluidremoval session; (b) acquire data regarding one or more target outcomesof a blood fluid removal session; (c) determine whether at least one ofthe one or more target outcomes is within a predetermined range of a atleast one corresponding prior target outcome stored in a lookup table,wherein the lookup table comprises data regarding system parameters usedin one or more prior blood fluid removal sessions of the patient; (d)determine whether the at least one target outcome was achieved with thesystem parameters used in the prior blood fluid removal session; (e) ifthe at least one target outcome is determined to have been achieved,determine whether at least one of the patient parameters or time sincelast blood fluid removal session is within a predetermined range of atleast one corresponding parameter stored in the lookup table; and (f)initiate a blood fluid removal session employing the system parametersused the prior blood fluid removal session if the at least one patientparameter or time since last blood fluid removal session is determinedto be within a predetermined range.

A twenty-fourth aspect is a method carried out by a blood fluid removalsystem, comprising: (a) collecting first data regarding a patient, thedata including one or more of a physiological parameter and time sincelast blood fluid removal session; (b) collecting second data regardingsystem parameters employed in blood fluid removal sessions of thepatient; (c) determining, based on the first and second collected data,whether at least one physiological parameter of the patient improved asa result of the system parameters employed; (d) determining whether avalue of current patient data is within a predetermined range of acorresponding value of first collected data; and (e) employing thesystem parameters that resulted in improvement, if such parameters aredetermined to exist and if the current patient data is determined to bewithin the predetermined range.

A twenty-fifth aspect is a blood fluid removal system, comprising: (a) ablood fluid removal medium configured to remove blood from a patient,wherein blood enters the medium, fluid is removed from the blood, andblood exits the medium; (b) one or more control elements configured tocontrol (i) the rate at which the medium removed fluid from the blood or(ii) the concentration of electrolytes or pH in the blood that exits themedium; (c) one or more sensors configured monitor one or morephysiological parameter of the patient; (d) an input configured to allowentry of data regarding patient or system parameters; and (e) controlelectronics comprising memory and a processor, wherein the controlelectronics are in operable communication with the one or more sensorsand are operably coupled to the one or more control elements and theinput, wherein the control electronics are configured to carry out amethod according to aspect 24.

A twenty-sixth aspect is a system of aspect 25, wherein the blood fluidremoval medium and the control electronics are housed within a bloodfluid removal device.

A twenty-seventh aspect is a system of aspect 25 or claim 24, furthercomprising a computer readable, wherein the computer readable mediumcomprises instructions that cause the control electronics to carry outthe method according to aspect 24.

A twenty-eighth aspect is a blood fluid removal system comprising: (a) ablood fluid removal medium configured to remove blood from a patient,wherein blood enters the medium, fluid is removed from the blood, andblood exits the medium; (b) one or more control elements configured tocontrol (i) the rate at which the medium removed fluid from the blood or(ii) the concentration of electrolytes or pH in the blood that exits themedium; (c) one or more sensors configured monitor one or morephysiological parameter of the patient; (d) an input configured to allowentry of data regarding patient or system parameters; and (e) controlelectronics comprising memory and a processor, wherein the controlelectronics are in operable communication with the one or more sensorsand are operably coupled to the one or more control elements and theinput, wherein the control electronics are configured to: (i) collectfirst data regarding a patient, the data including one or more of aphysiological parameter and time since last blood fluid removal session;(ii) collect second data regarding system parameters employed in bloodfluid removal sessions of the patient; (iii) determine, based on thefirst and second collected data, whether at least one physiologicalparameter of the patient improved as a result of the system parametersemployed; (iv) determine whether a value of current patient data iswithin a predetermined range of a corresponding value of first collecteddata; and (v) employ the system parameters that resulted in improvement,if such parameters are determined to exist and if the current patientdata is determined to be within the predetermined range.

A twenty-ninth aspect is a computer-readable medium comprisinginstructions that, when executed by a blood fluid removal device, causethe device to (a) collect first data regarding a patient, the dataincluding one or more of a physiological parameter and time since lastblood fluid removal session; (b) collect second data regarding systemparameters employed in blood fluid removal sessions of the patient; (c)determine, based on the first and second collected data, whether atleast one physiological parameter of the patient improved as a result ofthe system parameters employed; (d) determine whether a value of currentpatient data is within a predetermined range of a corresponding value offirst collected data; and (e) employ the system parameters that resultedin improvement, if such parameters are determined to exist and if thecurrent patient data is determined to be within the predetermined range.

Thus, systems, devices and methods for ADAPTIVE SYSTEM FOR BLOOD FLUIDREMOVAL are described. Those skilled in the art will recognize that thepreferred embodiments described herein may be altered or amended withoutdeparting from the true spirit and scope of the disclosure, as definedin the accompanying claims.

In the claims that follow, the designators “first”, “second”, “third”and the like are used for purposes of distinguishing between elementsand not for purposes of enumerating the elements or for defining asequence of the elements. For example, a “third” data set does notnecessarily imply that there are three data sets but rather that the“third” data set is distinct from the “first” data set. By way offurther example, a “third” data set need not be obtained after a “first”data set.

What is claimed is:
 1. A method carried out by a blood fluid removalsystem, comprising: storing a second data in a most effective to datedata set; wherein the second data is data regarding system parametersemployed in a first blood fluid removal session of a patient; andwherein a first data is data regarding the patient, the first dataincluding one or more of a physiological parameter and time since lastblood fluid removal session prior to the first blood fluid removalsession of the patient; wherein at least one physiological parameter ismeasured in a dialysate; storing the second data in a least effective todate data set; determining whether at least one physiological parameterin a third data is closer to a target value than the first data; andreplacing the data in the most effective to date data set with a fourthdata if the third data is closer to the target value than the firstdata; wherein the third data is data regarding the patient, the dataincluding one or more of a physiological parameter and time since lastblood fluid removal session prior to a second blood fluid removalsession of the patient; wherein at least one physiological parameter ismeasured in a dialysate; and wherein the fourth data is data regardingsystem parameters employed in the second blood fluid removal session ofthe patient; determining whether at least one physiological parameter inthe third data is further from a target value than the first data; andreplacing the data in the least effective to date data set with thefourth data if the third data is further from the target value than thefirst data; and initiating a subsequent blood fluid removal session;wherein the subsequent blood fluid removal session employs the systemparameters in the most effective to date data set.
 2. The method ofclaim 1, wherein the physiological parameter is selected from bloodpressure and/or heart rate.
 3. The method of claim 1, wherein thephysiological parameter is selected from pH and/or concentration of anelectrolyte.
 4. The method of claim 3, wherein the electrolyte ispotassium.
 5. The method of claim 1, wherein the system parameterscomprise one or more of fluid removal rate and dialysate concentrationof one or more electrolyte.
 6. The method of claim 5, wherein theelectrolyte is potassium.
 7. A blood fluid removal system, comprising: ablood fluid removal medium configured to remove blood from a patient,wherein blood enters the medium, fluid is removed from the blood, andblood exits the medium; one or more control elements configured tocontrol (i) the rate at which the medium removes fluid from the blood or(ii) the concentration of electrolytes or pH in the blood that exits themedium; one or more sensors configured to monitor one or morephysiological parameter of the patient; an input configured to allowentry of data regarding patient or system parameters; and controlelectronics comprising memory and a processor, wherein the controlelectronics are in operable communication with the one or more sensorsand are operably coupled to the one or more control elements and theinput, wherein the control electronics are configured to carry out amethod of: storing a second data in a most effective to date data set;wherein the second data is data regarding system parameters employed ina first blood fluid removal session of a patient; and wherein a firstdata is data regarding the patient, the first data including one or moreof a physiological parameter and time since last blood fluid removalsession prior to the first blood fluid removal session of the patient;wherein at least one physiological parameter is measured in a dialysate;storing the second data in a least effective to date data set;determining whether at least one physiological parameter in a third datais closer to a target value than the first data; and replacing the datain the most effective to date data set with a fourth data if the thirddata is closer to the target value than the first data; wherein thethird data is data regarding the patient, the data including one or moreof a physiological parameter and time since last blood fluid removalsession prior to a second blood fluid removal session of the patient;wherein at least one physiological parameter is measured in a dialysate;and wherein the fourth data is data regarding system parameters employedin the second blood fluid removal session of the patient; determiningwhether at least one physiological parameter in the third data isfurther from a target value than the first data; and replacing the datain the least effective to date data set with the fourth data if thethird data is further from the target value than the first data; andinitiating a subsequent blood fluid removal session; wherein thesubsequent blood fluid removal session employs the system parameters inthe most effective to date data set.
 8. The system of claim 7, whereinthe blood fluid removal medium and the control electronics are housedwithin a blood fluid removal device.
 9. The system of claim 7 furthercomprising a computer readable medium, wherein the computer readablemedium comprises instructions that cause the control electronics tocarry out the method.
 10. The system of claim 7, wherein thephysiological parameter is selected from blood pressure and/or heartrate.
 11. The system of claim 7, wherein the physiological parameter isselected from pH and/or concentration of an electrolyte.
 12. The systemof claim 11, wherein the electrolyte is potassium.
 13. The system ofclaim 7, wherein the system parameters comprise one or more of fluidremoval rate and dialysate concentration of one or more electrolyte. 14.The system of claim 13, wherein the electrolyte is potassium.
 15. Ablood fluid removal system comprising: a blood fluid removal mediumconfigured to remove blood from a patient, wherein blood enters themedium, fluid is removed from the blood, and blood exits the medium; oneor more control elements configured to control (i) the rate at which themedium removes fluid from the blood or (ii) the concentration ofelectrolytes or pH in the blood that exits the medium; one or moresensors configured to monitor one or more physiological parameter of thepatient; wherein at least one physiological parameter of the patient ismeasured in a dialysate; an input configured to allow entry of dataregarding patient or system parameters; and control electronicscomprising memory and a processor, wherein the control electronics arein operable communication with the one or more sensors and are operablycoupled to the one or more control elements and the input, wherein thecontrol electronics are configured to: receive first data regarding apatient, the data including one or more of a physiological parameter andtime since last blood fluid removal session prior to a first blood fluidremoval session of the patient; receive second data regarding systemparameters employed in the first blood fluid removal session of thepatient; determine, based on the first and second received data, whetherat least one physiological parameter of the patient improved as a resultof the system parameters employed; determine whether a value of currentpatient data is within a predetermined range of a corresponding value offirst received data; received third data regarding the patient, the dataincluding one or more of a physiological parameter and time since lastblood fluid removal session prior to a second blood fluid removalsession of the patient; wherein at least one physiological parameter ismeasured in a dialysate; receive fourth data regarding system parametersemployed in the second blood fluid removal session of the patient; storethe second data in a most effective to date data set; store the seconddata in a least effective to date data set; determine whether at leastone physiological parameter in the third data is closer to a targetvalue than the first data; and replace the data in the most effective todate data set with the fourth data if the third data is closer to thetarget value than the first data; determine whether at least onephysiological parameter in the third data is further from a target valuethan the first data; and replace the data in the least effective to datedata set with the fourth data if the third data is further from thetarget value than the first data; employ the system parameters thatresulted in the data in the most effective to date data set.
 16. Anon-transitory computer-readable medium comprising instructions that,when executed by a blood fluid removal device, cause the device to:store a second data in a most effective to date data set; wherein thesecond data is data regarding system parameters employed in a firstblood fluid removal session of a patient; and wherein a first data isdata regarding the patient, the first data including one or more of aphysiological parameter and time since last blood fluid removal sessionprior to the first blood fluid removal session of the patient; whereinat least one physiological parameter is measured in a dialysate; storethe second data in a least effective to date data set; determine whetherat least one physiological parameter in a third data is closer to atarget value than the first data; and replacing the data in the mosteffective to date data set with a fourth data if the third data iscloser to the target value than the first data; wherein the third datais data regarding the patient, the data including one or more of aphysiological parameter and time since last blood fluid removal sessionprior to a second blood fluid removal session of the patient; wherein atleast one physiological parameter is measured in a dialysate; andwherein the fourth data is data regarding system parameters employed inthe second blood fluid removal session of the patient; determine whetherat least one physiological parameter in the third data is further from atarget value than the first data; and replacing the data in the leasteffective to date data set with the fourth data if the third data isfurther from the target value than the first data; and initiate asubsequent blood fluid removal session; wherein the subsequent bloodfluid removal session employs the system parameters in the mosteffective to date data set.
 17. The non-transitory computer-readablemedium of claim 16, wherein the physiological parameter is selected fromblood pressure and/or heart rate.
 18. The non-transitorycomputer-readable medium of claim 16, wherein the physiologicalparameter is selected from pH and/or concentration of an electrolyte.19. The non-transitory computer-readable medium of claim 18, wherein theelectrolyte is potassium.
 20. The non-transitory computer-readablemedium of claim 16, wherein the system parameters comprise one or moreof fluid removal rate and dialysate concentration of one or moreelectrolyte.